JP5834026B2 - Breast protection system and appliance - Google Patents

Description

This application is related to and has priority from US Provisional Patent Application No. 61 / 309,758, filed March 2, 2010, entitled “A protective system and device thefor”. The entire contents of which are hereby incorporated by reference.

  The present invention relates to a brace for supporting and positioning a subject's breast in prone position and protecting the breast and / or adjacent pain sensitive tissue from unwanted breast compression, displacement, abnormalities or pain. This brace can be used, inter alia, during clinical examinations and / or clinical treatments, during radiological or other procedures, during mammary pain (breast pain), or for mactomy, breast augmentation or breast reconstruction. It is particularly useful in clinical situations such as after or during physical therapy or massage. This brace also finds use for personal use while resting in the prone position outside the clinic, such as, without limitation, during mammary pain, or after masotomy, breast augmentation or breast reconstruction. Can be found.

  Bibliographic details of the publications referred to by author in this specification are collected at the end of the description.

  References to any prior art in this specification shall not be construed as an acknowledgment that the prior art forms part of the common general knowledge in any country, or as an indication of any form thereof, And should not be interpreted as such.

  The breast is composed of glandular, fatty, and fibrous tissue that lies over the chest wall of the chest wall and is attached to the chest wall by a fibrous Cooper ligament. Adipose tissue surrounds the glands of the breast that extend throughout the breast, which imparts flexibility to the breast.

  Prone rest, such as in prone position, can cause pain in breast tissue due to pressure and displacement of the pain-sensitive breast tissue, even in clinical situations such as during physical therapy or massage, or simply relaxing during sunbathing. And can cause discomfort. This problem is exacerbated when the breast is particularly tender or when the anatomy is altered. Breast tenderness (mammary pain, mastodynia or breast pain) is, for example, during menstruation, pregnancy, during adolescence or breastfeeding, if there is mastitis or fibrocystic breast tissue, or Can increase as an adverse reaction to the medication. Postoperative patients with mactomy having extensive scar tissue feel pain when prone. Breast augmentation patients complain of pain caused by compression and displacement of the breast, scar and implant tissue when prone. Indeed, such compression or displacement of breast tissue can cause complications such as implant damage and / or implant movement and adjacent tissue damage. Proper positioning of the breast is crucial, for example, to reduce discomfort during mammography or other radiological examinations, thereby also improving examination accuracy. Further, chest wall imaging is improved if the breast is kept in place during radiological examination.

  In the past, clinic tables and other devices have been created that address some of these problems by providing direct cushioning or generally breast-shaped breast recesses. Prior art devices generally have failed to take into account breast position variations and individual size and skeletal variations well. A medical table having a breast insertion recess is disclosed, for example, in US Pat. No. 7,636,967. Another solution uses an oval pillow with two openings into which the breast can be inserted, as disclosed in US Pat. No. 7,426,762. Neither U.S. Pat. No. 7,636,967 or U.S. Pat. No. 7,426,762 provides excellent control of or protection of breast tissue.

  There is a need in the art for improved systems and devices for protecting and positioning a subject's breast tissue during prone position.

  According to a first aspect of the present invention, there is provided an appliance (protective pad) disposed on a surface so as to be located adjacent to a subject's breast lying in a prone position on a support surface, the appliance comprising: (A) a central portion that extends along the longitudinal axis of the brace to be acceptable between the breasts of the subject and supports the sternum; and (b) extends outwardly from the cranial edge of the central portion to both sides. Opposing portions ("cranial portion") that support the clavicle and / or upper rib cage / costal cartilage; and / or (c) extend laterally outward from the caudal end of the central portion to the lower rib cage / Includes opposing portions ("caudal portions") that support the costal cartilage and / or the upper abdomen, these portions being spaced laterally outward of the longitudinal axis, with the breasts on the outside and / or on the outside It is configured to displace and occupy those spaces.

  According to a second aspect of the invention, there is provided a method for supporting an upper torso of a subject lying in a prone position relative to a support surface, wherein the brace as defined herein comprises a breast of the subject. Positioned between the object and the support surface so as to be located adjacent to each other, so that the central part supports the sternum and the opposing part is the clavicle and / or the upper rib cage / costal cartilage and / or the lower rib cage / costal cartilage And / or support the upper abdomen, thereby displacing outward and / or upper and outer so that the breast occupies space.

  Preferably, the brace is configured to elastically deform when engaged by a subject.

  Preferably, the brace is configured to engage the subject in a cushioning manner.

  The brace can advantageously engage the subject in a manner that does not capture the periphery of the breast, regardless of the size of the breast.

  Preferably, the central portion is convex upwards when viewed along its length, i.e. in a cross-section perpendicular to the longitudinal axis.

  Preferably, the brace includes a caudal portion.

  Preferably, the caudal portion is integrally formed.

  Preferably, each of the caudal portions is upwardly convex when viewed in a cross section perpendicular to the axis with which it contacts the object.

  Preferably, adjacent edge portions of the central portion and the caudal portion form a curve that defines a lateral inner caudal boundary of the space. Thus, the edge portion may have a curved profile when viewed in a cross-section parallel to the surface when the brace is placed on the support surface.

  In a preferred embodiment of the present invention, the approximate curvature center of each curve is above and outside the position where the respective adjacent edge portions meet.

  Preferably, the brace is configured to provide relief between the caudal portions to reduce or remove pressure on the xiphoid process. Preferably, the relief includes a recessed surface recessed in the upper surface of the brace.

  Preferably, the caudal portion is configured to contact the subject along an axis that diverges in the caudal direction about the longitudinal axis. Preferably, each of the axes makes an angle of about 65 ° to about 85 ° with the longitudinal axis. More preferably, each angle is from about 70 ° to about 80 °. Even more preferably, each angle is about 75 °.

  Preferably, the caudal portion is upwardly convex when viewed in a cross section orthogonal to their axes.

  Preferably, the brace includes a cranial portion.

  Preferably, adjacent edge portions of the central portion and the cranial portion form a curvature that defines a lateral inner cranial boundary of the space. Accordingly, these adjacent edge portions may have a curved profile when viewed in a cross-section parallel to the surface when the brace is placed on the support surface.

  Preferably, adjacent edge portions of the central portion and the caudal portion form a curve that defines a lateral inner caudal boundary of the space.

  Preferably, the cranial portion is integrally formed.

  Preferably, the cranial portion is upwardly convex.

  Preferably, the brace is configured with a relief between the cranial portions to suppress or remove pressure on the trachea and / or jugular vein notch to facilitate breathing.

  Preferably, the cranial portion is configured to contact the subject along an axis that diverges in the cranial direction about the longitudinal axis. Preferably, each of these axes makes an angle of about 50 ° to about 70 ° with the longitudinal axis. More preferably, each angle is from about 55 ° to about 65 °. Even more preferably, each angle is about 60 °.

  Preferably, the cranial portion is upwardly convex when viewed in a cross section orthogonal to their axes.

  Preferably, the brace is open outward on both sides of the central portion.

  Preferably, the brace has a generally I-shaped configuration.

  Preferably, the brace is formed of an elastically deformable material.

  Preferably, the brace is a substantially solid structure.

  Preferably, the brace is formed with at least one cavity disposed below the outer surface of the brace that is exposed when the brace is placed on the support surface to facilitate the deformation of the brace.

  Preferably, this or each cavity includes a recess recessed in the lower surface of the appliance.

  Preferably, this or each cavity is located below the line where the brace is engaged by the object.

  Preferably, the brace includes the cavity configured to be placed under the xiphoid process when the brace is engaged by a subject.

  Preferably, the brace is configured with smoothly curved edge portions that define laterally inner boundaries of substantially C-shaped and inverted C-shaped, respectively, of the space.

  According to a third aspect of the present invention, an appliance as defined above in use is provided.

  According to a further description of the invention, there is provided an appliance (protective pad) that is placed between the subject's breasts when lying prone on the support surface, the appliance extending between the subject's breasts. A central portion, an upper (head side) portion extending outwardly from the central portion toward the opposite side of the subject, and a lower portion of the breast from the central portion; One or more of a lower (caudal) portion extending outwardly toward the side, wherein both sides of the brace define a space between the upper portion and the lower portion, respectively Allows the breasts to be displaced outwardly or outwardly into the space.

  In another description, the present invention provides a brace (protective pad) disposed adjacent to a subject's breast when lying prone and resting on a support surface, the brace comprising at least (a) the subject's breast A central portion extending between the breasts, and (b) an upper (cranial) portion extending above the breast and outwardly from the position of the central portion toward the opposite side of the subject, and / or (c ) Including any of the lower (caudal) portions extending downwardly from the breast and outwardly from the position of the central portion toward the opposite side of the subject, where both sides of the brace define a space , Allowing the breast to be displaced outwardly and / or top-to-outside into the space.

  In some embodiments, the brace includes (a) and (b). In other embodiments, the brace includes (a) and (c). In some embodiments, the brace includes (a), (b), and (c).

  In some embodiments, the brace, in use, is positioned under the sternum and clavicle and / or upper thoracic / costal cartilage, or alternatively or in addition, under the lower thoracic / costal cartilage and / or abdomen, Here, the brace takes the compressive load and diverts it from pain sensitive breast tissue and distributes it to a less painful body part adjacent to the brace.

  Preferably, the brace is in the form of a protective pad. Preferably, the brace is a single piece. Preferably, the brace is symmetric about the longitudinal axis. Preferably, the brace is elastically deformable. Preferably, the brace is a molded structure.

  The above summary is and is not to be considered as an exhaustive list of all embodiments of the present invention in any way.

  Some figures contain color representations or entities. Color plates are available upon request from the patent owner or from the appropriate patent office. A fee may be charged if obtained from the Patent Office.

FIG. 6 is an example appliance showing various parts and attributes. The appliance comprises one or more of parts (i), (ii) and (iii) forming exemplary part (a); parts (ii), (iv) forming exemplary part (b) And one or more of (v); and one or more of parts (iii), (vi) and (vii) forming exemplary part (c). In some embodiments, part (ii) may be part of part (a) or part (b) and part (iii) is part of part (a) or part (c) Good. Thus, in some embodiments, portion (b) (an opposing cranial portion generally facing the subject's head in use) comprises (iv) and (v), while (ii) when present , Part of the central part (a). Similarly, in some embodiments, when part (c) (the opposing caudal part generally facing the subject's foot in use) comprises parts (vi) and (vii), while present (iii) ) Form part of the central portion. FIG. 1 also shows the longitudinal support axis (also referred to as the central symmetry axis) of the brace and the lateral medial temporal and caudal boundaries of the space. The engagement line is such that the brace in some embodiments contacts the subject along an axis that diverges in the caudal direction (β) or cranial direction (α) about the longitudinal axis. Indicates whether it is configured. The shadow is (1) a substantially upwardly convex configuration when viewed in a cross section perpendicular to the line engaging the subject; (2) pressure on the trachea and / or jugular vein notch to facilitate breathing. Reliefs between the cranial parts and / or at the cranial edge of the central part for suppressing or removing cranial parts; and (3) between the caudal parts for suppressing or removing pressure on the xiphoid process and / or Or shows the contour of an exemplary brace, including a relief at the caudal end of the central portion. 2 is a sketch of an exemplary brace showing some of the brace dimensions that can change in response to anthropometric variation. In addition, the depth and contour of the brace can vary. The size of the arc formed by each surface of the brace can also vary. 1, 5 and 6 show various sized appliances. FIG. 6 is a photographic representation showing the contact and relative position of the brace part to the prone skeleton. FIG. (FIG. 8 of provisional specification) It is a photograph expression which shows the contact and relative position of the part of the orthosis with respect to the frame | skeleton of a supine position. FIG. 5 provides a photographic representation showing three exemplary appliances (A-C) of the present invention, 5A (i) in a plan view with the head side portion (upper end or upper end) closer to the upper end of the page. The shading shows the engagement line, the upper and lower outer surface relief areas, and other features of the present invention; and 5B (ii) the inner tail in the tangential side view with the head side portion facing down on the page. The side boundary (ICuB) is highlighted, and (iii) the caudal part is facing down on the page, and the medial temporal boundary (ICpB) is highlighted. These braces were molded from an oil-extended thermoplastic styrene rubber-modified polypropylene compound filled with minerals and stabilized with UV light. (I) shows the three appliances (A, B and C) of the present invention in a side view with the caudal portion facing down on the page, and (ii) hollow hollow in some embodiments of the present invention Provide a photographic representation showing the bottom surface of a unitary brace that includes an excised portion or cavity (indicated by X) to provide greater deformability adjacent to the cavity. FIG. 3 is a graphical representation of data showing forces (N) and pressures (kPa) leading to breast tissue in a spine manipulation thrust on a subject with unmodified natural breast tissue, as described in Example 2. FIG. The left side of FIG. 7A provides a three-dimensional (3D) pressure image of the right breast at maximum load in the manipulation, showing that the breast tissue without the brace is subjected to high maximum pressure. The left side of FIG. 7B provides a 3D image of the breast when the force is maximum in the manipulation and shows that the indication of maximum force is greatly reduced in the presence of the brace. If the brace produced pressure against the sensor, those data were excluded from the display on the right side of the figure. The displayed image is a screen dump of the three-dimensional pressure image when the force is maximum, as shown by the spikes in the force versus time curve (middle graph on the right side of the figure). To simplify the display, the data from the two strips were combined. FIG. 3 is a graphical representation of data showing force (N) and pressure (kPa) leading to breast tissue in a spinal manipulation thrust for a subject LA with silicon augmentation as described in Example 2; FIG. 8A provides a pressure image of the right breast when the force is maximum in the manipulation and shows that it receives a high maximum force without the brace. FIG. 8B shows a greatly reduced pressure image of the right breast when the force is maximum in manipulation in the presence of the brace. The edge of the brace is displayed on the far left side of the figure so that the pressure on the brace can be seen. If the brace produced pressure against the sensor, those data were excluded from the display on the right side of the figure. The displayed image is a screen dump of the three-dimensional pressure image when the force is maximum, as shown by the spikes in the force versus time curve (middle graph on the right side of the figure). To simplify the display, the data from the two strips were combined. As described in Example 3, anteroposterior compression (AP) in the presence and absence of a prone load in the presence of a brace when measuring a subject with unmodified natural breast tissue And a representation of magnetic resonance imaging (MRI) data showing a decrease in mesolateral displacement (ML). As shown in the two images below, the presence of the brace reduces the pressure in the front-rear direction when lying in the prone position compared to the same subject without the brace, and the displacement in the medial and lateral directions Decreased. As described in Example 3, anteroposterior compression (AP) and medial-lateral direction with and without a load in the prone position in the presence of a brace for a subject with silicon augmentation 2 is a representation of magnetic resonance imaging (MRI) data showing a graph of displacement (ML) reduction. As shown in the middle of the two images below, the presence of the brace reduced the anteroposterior compression and the displacement in the medial and lateral directions compared to the same object without the brace.

  Throughout this specification and the claims that follow, the terms “comprise” and “comprises” and “comprising” unless the context requires otherwise. Variations such as imply an integral or step or group of completes or steps as described, but imply the exclusion of any other whole or step or group of completes or steps. It is understood that it is not a thing.

  As used herein, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to “an orthosis” includes a single appliance, as well as two or more appliances; a reference to “an elastomer” includes an elastomer, and For example, two or more elastomers are included.

  Each embodiment of the present specification shall be applied to all other embodiments with changes to be made unless otherwise specified.

  The inventor has developed a brace that diverts compression and displacement pressure away from pain-sensitive breast tissue and directs it to structurally more robust tissues including the sternum, clavicle and rib cage. In some embodiments, the brace can be guided by the brace in the extent to which the breast tissue is displaced and occurs in the most preferred lateral and / or superior lateral direction, and the movement is caused by any part of the brace. It is configured to ensure that it is not hindered. Preferably, the breast tissue is displaced towards the anterior or auxiliary fold.

  According to a first aspect of the present invention, there is provided an appliance (protective pad) disposed on a surface so as to be located adjacent to a subject's breast lying in a prone position on a support surface, the appliance comprising: (A) a central portion that extends along the longitudinal axis of the brace to be acceptable between the breasts of the subject and supports the sternum; and (b) extends outwardly from the cranial edge of the central portion to both sides. Opposing portions ("cranial portion") that support the clavicle and / or upper rib cage / costal cartilage; and / or (c) extend laterally outward from the caudal end of the central portion to the lower rib cage / Includes opposing portions ("caudal portions") that support the costal cartilage and / or the upper abdomen, these portions being spaced laterally outward of the longitudinal axis, with the breasts on the outside and / or on the outside It is configured to displace and occupy those spaces.

  In some embodiments, the present invention provides a brace that is placed adjacent to the subject's breast when lying prone on the support surface. In particular, the brace is effective in reducing breast tissue compression and / or displacement, or pain associated with breast tissue compression, and improving breast positioning during radiological, surgical, or other procedures. is there. In some embodiments, the brace is located at least under the sternum body, where the brace accepts compressive loads and diverts from pain-sensitive breast tissue, such as the sternum, abdomen, costal cartilage, rib cage, or clavicle. Distribute to body parts with lower pain sensitivity. In some embodiments, the side of the brace defines a space in which breast tissue can be comfortably displaced during compression. In some embodiments, the degree to which breast tissue is compressed and / or displaced under a compressive load is reduced compared to breast tissue compression and / or displacement in the absence of a brace.

  In some embodiments, the brace controls and reduces breast tissue compression and / or displacement while lying in a prone position, including during clinical examination or physical therapy.

  As used herein, the term “adjacent” includes ranges above and / or below and / or between breast ranges (both breasts).

  In some embodiments, the brace is positioned, in use, under the sternum and clavicle and / or upper thoracic / costal cartilage, or alternatively, or in addition, under the lower thoracic / costal cartilage and / or abdomen. Here, the brace takes the compressive load and diverts it from pain sensitive breast tissue and distributes it to less painful body parts lying on the brace, such as the sternum, abdomen, costal cartilage, rib cage and collarbone. This is shown in FIGS. 3 and 4, which show where the range of the skeleton intended to place the brace below in use relative to the skeletal or supine skeleton, respectively. 1 shows an exemplary orthotic model.

  In some embodiments, the brace has a central axis of symmetry that aligns with the sternum at the midline of the subject's body in use.

  The compressive load can result from the weight of the subject's upper body or from a load applied to the upper body, typically the back of the spine or thorax, for example during physical therapy or massage. In some embodiments, the brace is elastically deformable.

  Compared to prior art devices for positioning the breast during procedures such as radiology, massage, and spinal manipulation, without being bound by any particular mechanism of action, the present invention provides relative use. Offers greater ease and safety, comfort and higher capabilities, as well as improved alignment and positioning. In addition, the device can be well exposed to the axillary lymph system.

  The dimensions of the brace and part are selected in part for stability and comfort, and the compressive load of the subject or subject is adjacent to the breast and adjacent by the brace, corresponding to anthropometric variation in the subject population. It is selected to ensure that it is diverted away from pain sensitive tissue. As shown in FIGS. 1 and 2 described in FIGS. 5 and 6, the various dimensions of the brace can vary. However, an I-shaped or C-shaped configuration with open sides ensures that capture of the breast by a brace that is not individually adapted will not occur whatever the size of the breast.

  In some embodiments, the brace is contoured for comfort and to avoid pinching the tissue during use. Thus, the brace is advantageously shaped, in particular such that at least the side of the brace facing the breast is gradually inclined to make smooth contact with the breast tissue in use.

  In some embodiments, the brace is configured to elastically deform when engaged by a subject. In other embodiments, the brace is configured to engage the subject in a cushioning manner. Advantageously, the brace engages the subject in a manner that does not capture the periphery of the breast, whatever the size of the breast.

  In some embodiments, the central portion is upwardly convex when viewed along its length, i.e., in a cross section orthogonal to the longitudinal axis.

  In some embodiments, the brace is open outward on both sides of the center. In the exemplary embodiment, the brace has a generally I-shaped configuration. In some embodiments, the brace is formed of an elastically deformable material. In other embodiments, the brace is a substantially solid structure.

  In some further embodiments, the brace is configured to provide relief between the caudal portions to suppress or remove pressure on the xiphoid process. In some embodiments, the caudal relief includes a recessed surface recessed in the upper surface of the brace (outer surface or surface with which the object contacts). In other embodiments, the brace is configured to include a relief between the cranial portions to suppress or remove pressure on the trachea and / or jugular vein notch to facilitate breathing. In some embodiments, the cranial relief includes a recessed surface recessed in the upper surface (outer surface) of the brace.

  In other embodiments, the brace is formed with at least one cavity that facilitates deformation of the brace disposed below the outer surface of the brace that is exposed when the brace is disposed on the support surface. The In some embodiments, this or each cavity includes a recess recessed in the lower surface of the brace. In some embodiments, this or each cavity is located below the line where the brace is engaged by the subject. In some embodiments, the brace includes the cavity configured to be placed under the xiphoid process when the brace is engaged by a subject.

  In some embodiments, the brace is configured with smoothly curved edge portions that define a substantially C-shaped and inverted C-shaped lateral inner boundary, respectively, of the space.

  In a preferred embodiment, the brace includes a caudal portion. In some embodiments, these caudal portions are integrally formed.

  In the exemplary embodiment, each of the caudal portions is upwardly convex when viewed in a cross section perpendicular to the axis with which it contacts the object.

  In another exemplary embodiment, adjacent edge portions of the central portion and the caudal portion form a curve that defines a lateral inner caudal boundary of the space. These are shown in the figure (see FIG. 1). Thus, the edge portion may have a curved profile when viewed in a cross-section parallel to the surface when the brace is placed on the support surface. In some embodiments of the invention, the approximate center of curvature of each curve is above and outside the position where the respective adjacent edge portions meet.

  In an exemplary embodiment, the caudal portion is configured to contact the subject along an axis that diverges in the caudal direction about the longitudinal axis. In some embodiments, each of the axes makes an angle of about 65 ° to about 85 ° with the longitudinal axis (see the angle labeled β in FIG. 1). In some embodiments, each angle is between about 70 degrees and about 80 degrees. In yet another embodiment, each angle is about 75 °.

  In some embodiments, the brace includes a cranial portion.

  In the exemplary embodiment, adjacent edge portions of the central portion and the cranial portion form a curvature that defines a lateral medial temporal boundary of the space. Accordingly, these adjacent edge portions may have a curved profile when viewed in a cross-section parallel to the surface when the brace is placed on the support surface. In some embodiments, adjacent edge portions of the central portion and the caudal portion form a curvature that defines a lateral inner caudal boundary of the space.

  In some embodiments, the cranial portion is integrally formed. In other embodiments, the cranial portion is convex upward when viewed in a cross-section orthogonal to the axis.

  Preferably, the cranial portion is configured to contact the subject along an axis that diverges in the cranial direction about the longitudinal axis. Preferably, each of these axes makes an angle of about 50 ° to about 70 ° with the longitudinal axis (see the angle marked α in FIG. 1). More preferably, each angle is from about 55 ° to about 65 °. Even more preferably, each angle is about 60 °.

  In another description, the present invention provides a brace that is positioned adjacent to a subject's breast when lying prone on a support surface, the brace comprising: (a) a subject's breast A central portion extending between; (b) an upper portion extending above the breast and outwardly from the central portion toward the opposite side of the subject; and (c) a subject from the central portion below the breast. Including one or more lower portions extending outwardly toward opposite sides, wherein the side of the brace facing the breast defines a space, each breast outwardly into the space Alternatively, it is possible to displace upward and outward.

  In some embodiments, the brace comprises (a) and (c) and / or (b). One or more lower caudal portions are particularly important for distributing the breast tissue outward. Thus, in some embodiments, one or more upper temporal portions are not present.

  In some embodiments, the brace comprises (a), (b) and (c) as described herein and as shown in FIGS. 1, 5 and 6.

  In another embodiment, the present invention provides an appliance disposed between a subject's breasts when lying prone on a support surface, the appliance comprising a central portion extending between the subject's breasts; An upper part extending outward from the central part toward the opposite side of the object above the breast and an outward part extending from the central part toward the opposite side of the object below the breast Wherein both sides of the brace define a space between the upper and lower portions and each breast is displaced outwardly or upwardly and outwardly into the space. to enable.

  The term “portion” includes any part of a single brace (pad), and thus the term refers to a region of the brace. The term further refers to a separate part of the brace manufactured as a separate pad and used individually or in conjunction with other pads. Any number of separate parts can be used depending on the needs of the situation.

  In some embodiments, the brace is a single piece.

  In some embodiments, the brace has a central axis of symmetry that extends between the subject's breasts when in use.

  In one particular but not essential embodiment, the brace is elastically deformable.

  Conveniently, the appliance is made, such as without limitation, from an elastically deformable material or one or more precursors thereof. It is proposed that the elastically deformable material be adapted to transmit compressive forces to a less pain sensitive appliance contact surface. In some embodiments, the brace is made with an inner deformable material and an outer casing. This embodiment includes a filled or fillable bladder. The bladder may be filled with air, gas mixture, gel, liquid or semi-solid material or the like.

  As is known in the art, the sternum is an elongated flat bone that forms the central portion of the anterior chest wall. Its front end supports the clavicle and its rim is articulated with the first seven pairs of rib cartilage. The sternum is made up of three parts: the “sternum” at the top, which has a square shape, is narrow, merges with the long and thin “sternum”, and the “xiphoid process” at the bottom.

  Costal cartilage is a hyaline-rich rod-like cartilage that provides great elasticity to the chest wall. The side of each cartilage continues to the ribs. In older subjects, at least the surface of costal cartilage tends to ossify.

  In further description, the present invention provides a brace (protective pad) that is placed adjacent to the subject's breast area when lying prone and resting on a support surface, the brace comprising one of the following parts: Or a plurality of: (a) a central sternum portion mounted on a support surface and extending upwardly toward the subject's sternum and extending axially along the midline between the breasts; (b) support Placed on the surface and extends upwards toward the subject above (head / upside) the central sternum, thereby contacting the subject in the area of the collarbone and / or upper rib cage / costal cartilage above the breast An upper clavicle portion that supports (supports it); and (c) rests on the support surface and extends upwardly toward the subject below the caudal portion (caudal / posterior) from the breast Contact the subject in the lower lower rib cage / costal cartilage and / or abdominal area It is supported) lower thorax section.

  In some embodiments, both sides of the brace define a space between the upper and lower portions, allowing each breast to be displaced outwardly or outwardly into the space. .

  Each brace may be manufactured as two or more separate parts that are used separately or simultaneously.

  In another aspect, the present invention provides a brace that is positioned adjacent to a subject's breast when lying prone on a support surface, the brace being (a) mounted on the support surface; And a central sternal portion extending upwardly (and supporting it) towards the subject's sternum and extending axially along the midline between the breasts; and (b) mounted on the support surface; An upper clavicle portion that contacts (supports) the clavicle and / or upper rib cage / costal cartilage above the breast by extending upwardly toward the subject above the central portion; and (c) on the support surface A lower thoracic portion that is mounted and extends upwardly toward the subject below the central sternum portion and in contact with (supports) the lower thoracic / costal cartilage and / or abdomen below the breast Including.

  In some embodiments, the brace or portion thereof has a generally rectangular bottom surface and a side facing the breast tissue having a round semi-circular axial cross section that is tapered at the bottom. In some embodiments, the bottom surface is flat. In another embodiment of the invention, the bottom surface is substantially concave.

  In some embodiments, portion (a) extends at least along the length of the sternum.

  In some embodiments, portion (a) extends along the length of the sternum and below the length of the sternum.

  In some embodiments, part (a) and / or part (c) avoids contact with the xiphoid process, for example that the brace terminates above the procession, or By tapering the brace in that area (providing relief to the brace).

  In some embodiments, portion (c) extends across the lower rib cage / costal cartilage.

  This is shown in FIGS. 1C, 7 and 8 of the provisional specification. Here, the pad portion C includes a portion (iii) as shown in FIG. 1, and further includes portions (vi) and (vii).

  In other exemplary embodiments, see FIGS. 4-7 of the provisional specification, the central sternum portion (a) includes portions (i) and (ii) as shown in FIG. The costal cartilage portion includes two portions that are joined or overlapped below the central sternum portion as shown in FIGS.

  In some embodiments, portion (b) extends across the clavicle. This is shown in FIG. Here, the pad including the portion (ii) further includes the portions (iv) and (v).

  Thus, the exact boundaries and sub-configuration of each part as generally described herein has the flexibility to allow small variations in the configuration of the device with no substantial change in its functional operation.

  In some embodiments, portion (b) extends across the clavicle.

  In some embodiments, the depth of the brace is substantially uniform axially along the sternum portion. In some embodiments, the brace is manufactured as a single building block.

  In other embodiments, the brace parts are manufactured as separate units and used separately or together. In some embodiments, the parts may be further divided and manufactured as separate units that are combined in use. The figure showing the brace of the present invention includes a sternum / central portion, a clavicle / upper / cranial portion, and a lower / lower thoracic / caudal portion for diverting load pressure away from the pressure sensitive breast and adjacent tissue A single (single) device is shown.

  In some embodiments, the upper and lower portions of the brace are connected to each other only through the central portion. In some embodiments, two or three or more separate parts or small parts of the brace are removably interconnected.

  In a detailed embodiment, the brace is open on the side, allowing breast tissue to be displaced laterally. In a further embodiment, an undisturbed lateral displacement towards the front or auxiliary fold is provided. In some embodiments, each part of the brace is configured to distribute the breast tissue outward or superior and outward in use and divert the compressive load away from the breast tissue and distribute it to the musculoskeletal structure adjacent to each part. The

  In some embodiments, one or more appliances and / or any portion thereof, optionally of varying dimensions, are sold as a kit, optionally with instructions for use.

  According to a second aspect of the present invention, there is provided a method for supporting an upper torso of a subject lying in a prone position relative to a support surface, wherein the brace as defined herein comprises a breast of the subject. Positioned between the object and the support surface so as to be located adjacent to each other, so that the central part supports the sternum and the opposing part is the clavicle and / or the upper rib cage / costal cartilage and / or the lower rib cage / costal cartilage And / or support the upper abdomen, thereby displacing outward and / or upper and outer so that the breast occupies space.

  The brace is configured to reduce the force applied to the breast tissue while lying in the prone position, including compression and displacement of the breast and adjacent tissue.

  The present invention provides a system for positioning a subject's pain-sensitive breast tissue and protecting it from compressive loads, etc. while lying prone on a support surface, the method adjacent to the breast Providing a brace as defined herein to ensure that positioning and distribution of compression and / or displacement loads to a lower pain-sensitive range above the brace; Wherein the brace is (a) a central sternum portion that rests on the support surface and extends upwardly toward the subject's sternum and extends axially along the midline between the breasts; ) An upper clavicle portion that rests on the support surface and extends upwardly toward the subject above the central portion so as to contact the clavicle above the breast and / or the upper rib cage / costal cartilage; and (c) Mounted on support surface It is, and the upwardly to extend towards the target at below the central portion, including one or more lower rib cage portion in contact with the lower rib cage / costal cartilage and / or abdomen below the breast.

  In some embodiments, the system is used during radiological or other procedures involving the breast, such as during mammography or chest imaging. The system includes selecting a suitable appliance or part thereof for a particular subject. Given the configuration with open sides, each brace can be suitable for a wide range of target sizes.

  In some embodiments, the brace comprises part (a), part (b) and part (c) as a single building block or as separate parts. In some embodiments, the brace comprises (a) alone; (b) alone or (c) alone, each of these parts being alone or separate parts or parts (small parts) It may be as. In some embodiments, parts (a) and (b), (a) and (c), or (b) and (c) are separate parts, or (a) and (b) or ( In the case of a) and (c), it is a simple substance.

  Thus, the brace may be a single piece or may be composed of portions that can be positioned adjacent or overlapping.

  As described herein, the degree of breast tissue compression and displacement is substantially in the presence of the brace when subjected to a compressive load, such as when lying in a prone position or during a spinal manipulation thrust. descend. This includes natural breast tissue or breast tissue augmented with implants such as silicon and saline implants.

  In some embodiments, the brace has a displacement that includes displacement in the medial and lateral directions and / or compression that includes anteroposterior compression, by at least about 50% in subjects with unmodified natural breast tissue, and Reduce by at least 10% in subjects with implants. As shown in the exemplary embodiment, the brace reduces the maximum force that is passed to the breast in the spinal manipulation thrust by at least 50% compared to the maximum force that is passed to the breast in the absence of the brace.

  In some embodiments, the displacement is reduced by at least about 55%, 60%, 65%, 70%, 75%, or 80% when the brace is present compared to the displacement without the brace.

  In some embodiments, compression is reduced by at least about 55%, 60%, 65%, 70%, 75%, or 80% when the brace is present, compared to the displacement without the brace.

  In some embodiments, the displacement is at least about 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21% in a subject with an implant, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38% , 39% or 40%.

  In some embodiments, compression is at least about 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, at least 20%, 21% in subjects with implants. 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38 %, 39% and 40%.

  In some embodiments, the maximum force on the breast is at least about 55%, 65%, 70%, 75%, 80%, 85%, 90 or 95 compared to the maximum force through the breast without the brace. Decrease by%.

  The deformable elastic material from which the brace can be made is selected from any one or more suitable compositions including, without limitation, natural or synthetic elastomer materials. The brace can be a gas, liquid, gel, emulsion, solid, particulate material (eg, sand, earth, beads, microspheres, grain, dried organic matter, eg, bean, pulse, rice, grain, seed, fruit, And macromolecular, monomeric or hybrid colloidal materials, or any combination thereof. In some embodiments, a reinforcing material and / or coating material is used that may be peelable.

  In some embodiments, the brace is an elastomeric composition. In this aspect of the invention, the brace can be any elastomeric composition having deformability and elasticity suitable for distributing compressive loads as described herein.

  In some embodiments, the elastomer is a thermoplastic or thermoset elastomeric polymer or copolymer. In some embodiments, the brace comprises or consists of rubber-modified polypropylene, such as an oil-extended thermoplastic styrenic rubber-modified polypropylene compound filled with minerals and UV stabilized.

  Suitable compositions are known to those skilled in the polymeric materials art. These include natural latex, isoprene, polyisoprene, polystyrene butadiene, nitrile elastomers, butyl elastomers, ethylene propylene terpolymers, silicone elastomers, neoprene, polysulfides, polyacetyl, eperchloride, fluoroelastomers, hyperon. ), Butyl halides, polyurethanes, and thermoplastic elastomers.

  The majority of synthetic rubber is derived from petroleum, coal, oil, natural gas, and acetylene. Suitable compositions and methods for making it are known to those skilled in the polymer and plastics arts. Exemplary polymers include Charrier, Jean-Michel, Polymer Materials and Processing: Plastics, Elastomer, and Composites, Oxford University Press, USA, 1991 and Gen, Alan N., et al. (Ed), Engineering With Rubber: How to Design Rubber Porters, 2nd Edition, Editor, Hansarder Publications, 2001.

  Polyurethane elastomers (spandex) are made from urethane (for strength) and polyether or polyester (for elasticity). Polyurethane elastomers are versatile elastomers due to their hardness, strength and oil resistance. Polyurethane elastomers are widely used in the production of foam for bedding. Nitrile elastomers are copolymers of acrylonitrile and dienes such as butadiene. Neoprene (polychloroprene) is useful for heavy duty applications. Butyl elastomer is a copolymer of isobutylene and isoprene (1.3%). Butyl elastomers are typically used in the manufacture of injection models and extruded products where good shock absorption is required. Butyl elastomers are also abrasion resistant. Styrene-butadiene copolymers (Buna S and SBR) are cis-polybutadiene and cis-polyisoprene formed by emulsion polymerization of various ratios of butadiene and styrene. Polymers are also usefully used.

  The ethylene-propylene copolymer is the same as SBR. These are often used for vehicle parts and footwear. Silicone elastomers are polymers of dimethylsilanediol. Polysulfide, sulfide and polyacrylic elastomers have valuable properties. They are used in particular for medical implants.

  The brace and parts thereof are manufactured in various sizes corresponding to variations in human measurement. In general, the braces and parts are manufactured with a depth of about 1 cm to about 20 cm at the deepest point (the point of contact with the sternum), but braces with larger or smaller depths are not excluded.

  A kit is contemplated, which may include a majority of subjects or their depending on the dimensions or average dimensions of breast (including rib cage, clavicle, sternum) and breast tissue (typically characterized by brassiere cup size). It includes a plurality of appliances (such as A, B and C shown in FIG. 5) and / or portions thereof that fit into some populations. Thus, the braces and parts are manufactured to fit objects with brassiere cup sizes from A to G and above. In some embodiments, the device is specially manufactured to fit a particular object.

  A removable connector between the parts is contemplated. Suitable connectors include, but are not limited to, a cooperating latch device constructed between the parts (eg, Velcro), or a male and female type of attachment device (eg, a snap connection) that is attached to or within the appliance part. And magnetic fastener devices. The removable connector may itself be removable and may be sold separately or together as part of the subject kit.

  The invention is further illustrated by the following non-limiting examples and figures.

Example 1 Exemplary Materials In an exemplary embodiment, the brace comprises an oil-extended thermoplastic styrenic rubber modified polypropylene compound that is filled with minerals and UV stabilized. While this compound has a low flow grade suitable for extrusion, it is shear thinning and has good mold filling ability for injection molding applications that fill the mold. This compound was developed to provide “soft feel” properties with maximum flexibility and low surface hardness. The braces were made in three different sizes A, B and C to accommodate all different size objects.

  The physical properties of the elastomeric pad can be evaluated by the following tests: indentation force displacement (IFD), compression load displacement (CLD),% compression set, tensile strength, elongation strength, tear strength, Rebound resilience, punchability, weldability, aging and / or fatigue (fatigue, rolling and constant force fatigue). Exemplary properties include: specific gravity 0.91; melt flow index 2.2; tension at 100% strain 0.3; tension at 300% strain 0.7; ultimate tensile strength 1. 6; Durometer A-17; Tear strength -8. Such characteristics may vary and may still be within the scope of the invention depending on the contingency of the situation. Charrier, Jean-Michel, Polymer Materials and Processing: Plastics, Elastomer, and Composites, Oxford University Press, USA, 1991 and Gent, Alan N. (Ed), Engineering With Rubber: How to Design Rubber Porters, 2nd Edition, Editor, and Hans Garner Publications, 2001.

  The material can be processed in most conventional extruders used for sheet or profile extrusion, however, multistage or twin screw types with vacuum venting are recommended. The processing temperature must be in the range of 160-180 ° C and the die temperature must be in the range of 160-180 ° C. These compounds are subject to a decrease in viscosity when used in a high shear screw, resulting in a decrease in melt strength. The melting temperature should be as close to the die temperature as possible to ensure good caliper control. Usually no pre-drying is necessary, however, pre-drying at about 60 ° C. for about 1-2 hours after storage over a long period of time or under high humidity conditions may be appropriate.

Example 2: The device provides a reduction in load through breast tissue when lying in the prone position, during spinal manipulation thrusts and during weight loading, as determined by pressure testing.
A test to determine the ability of a brace as defined herein and as shown in the figure to relieve pressure on the breast while lying in prone position and under load in prone position Carried out. The pressure test was performed by Dr. Patrick McLoughlin of School of Biomedical and Health Services, Victoria University, Melburne, Australia. For women whose brassiere cup size is natural or C-EE breast-enhanced by silicone, while lying in a prone position on a support surface with a capacitive sensor under the right breast In the presence or absence of. It contained three groups of 15 capacitive sensors, each group positioning two strips with an area of 1 cm ² under the right breast, the sensor sensing 4 kPa and having a sample rate of 50 Hz. . For each subject, the maximum force (N) and peak pressure (kPa) readings are measured in the presence or absence of the brace, (ii) while no external force is applied, and (ii) a 15 kg load is in the breast range. While on the upper back, (iii) taken while the spine above the breast area (during prone position) was undergoing a spinal manipulation thrust by an osteopath (not all subjects).

  The results for each subject are tabulated as Table 1. There was a maximum force reduction of at least about 50% in the presence of the brace for all subjects. CC cup sized subject C with unmodified natural breast tissue shows an 80% reduction in force through the breast with spinal manipulation in the presence of the brace and 95% at 15 kg load in the presence of the brace It showed a decrease in force (see FIG. 7A with no brace and FIG. 7B with brace). An EE cup-sized subject LA with a silicone implant showed a 65% reduction in force through the breast in spinal manipulation in the presence of the brace, and a 86% reduction in force received by the load in the presence of the brace ( (See FIG. 8A without the brace and FIG. 8B with the brace showing the pressure drop on the breast tissue).

Example 3: The subject, when determined by magnetic resonance imaging (MRI), shows a decrease in longitudinal compression (AP) and displacement in the medial and lateral direction (ML) in the presence of the device in the presence of the device.
Women with brassiere natural or C-EE breast augmented with silicon (as in Example 2) were evaluated by MRI while lying in the prone position on the support surface. MRI images of breast tissue for each subject in the presence or absence of a brace, while (i) no external force applied, and (ii) a 15 kg load on the back over the breast area I got it. The extent of AP compression and ML displacement under these conditions was determined by the instrument directly from the image data.

  For subjects with natural unmodified breasts, an approximately 45% reduction in AP compression and an approximately 28% reduction in ML displacement were observed in the presence of the device, as shown in FIG. An EE cup-sized subject LA with a silicon implant showed about 12% reduction in AP compression and about 14% reduction in ML displacement in the presence of the device (see FIG. 10).

  Many variations will be apparent to those skilled in the art without departing from the scope of the invention.

  The disclosures of all patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety.

Claims (17)

An appliance disposed on the surface to be positioned adjacent to a subject's breast lying in a prone position on a support surface and configured to elastically deform when engaged with the subject, the appliance But,
(A) a central portion that supports the sternum extending along the longitudinal axis or central symmetry axis of the brace so as to be acceptable between the breasts of the subject ;
(B) opposing portions that extend outwardly from the cranial edge of the central portion to both sides to support the clavicle and / or the upper rib cage / costal cartilage (“cranial portion”); and (c) the central portion Opposite portion that extends outward from the caudal end and supports the lower rib cage / costal cartilage and / or upper abdomen ("caudal portion")
Including
Said part, the longitudinal space laterally outward direction axis is defined, the breast is configured to be displaced outwardly to occupy the space,
The brace is formed with at least one cavity disposed below the outer surface of the brace that is exposed when the brace is disposed on the support surface to promote deformation of the brace. , Orthosis. Adjacent edges of said central portion and said tail portion forms a curved defining the lateral inside caudal border of said space, appliance according to claim 1. The appliance according to claim 1 or 2 , wherein a relief is provided between the caudal portions and configured to suppress or remove pressure on the xiphoid process. The caudal portion, the longitudinal axis or central axis center is configured to contact the subject along an axis diverging caudal direction, for each of those people is the longitudinal axis or central axis an angle of about 70 ° ~ about 80 ° Te, appliance according to any one of claims 1 to 3. The orthosis according to any one of claims 1 to 4 , wherein the caudal portion is upwardly convex when viewed in a cross section perpendicular to a line with which the caudal portion engages the object. The brace according to any one of the preceding claims, wherein adjacent edge portions of the central portion and the cranial portion form a curvature that defines a lateral inner cranial boundary of the space. 7. A relief according to any one of the preceding claims, comprising a relief between the cranial portions and configured to suppress or remove pressure on the trachea and / or jugular vein notch to facilitate breathing. The orthosis described. The cranial portion is configured to contact the object along an axis that diverges in a cranial direction about the longitudinal axis or a central axis, and each of the axes that diverge in the cranial direction is the longitudinal direction The appliance according to any one of the preceding claims, wherein the appliance is at an angle of about 55 ° to about 65 ° relative to the axis or central axis . The orthosis according to any one of claims 1 to 8 , wherein the cranial portion is upwardly convex when viewed in a cross section orthogonal to a line where the cranial portion engages the object. The orthosis according to any one of claims 1 to 9 , which opens outward on both sides of the central portion so as to have a substantially I-shaped configuration. The appliance according to any one of claims 1 to 10 , configured to be elastically deformed when engaged by the object. A brace formed with at least one cavity disposed below an outer surface of the brace that is an exposed surface when the brace is disposed on the support surface, wherein the one or more cavities 12. The brace of claim 11 , wherein the brace is located at a position where the brace is placed under the xiphoid process when engaged by the object, thereby facilitating deformation of the brace at that position. The appliance according to any one of claims 1 to 12, wherein the appliance is in the form of a protective pad. The orthosis according to any one of claims 1 to 13, wherein the axis is a central symmetry axis. 15. The appliance according to any one of the preceding claims, wherein the at least one cavity is a cavity configured to be placed under a xiphoid process when the appliance is engaged with the object. 16. The brace according to any one of claims 1 to 15, wherein the brace is open on the side so that the breast is not captured. A method for supporting an upper torso of an object lying in a prone position with respect to a support surface, wherein the appliance according to any one of claims 1 to 16 is located adjacent to the breast of the object. Positioned between the subject and the support surface, so that the central portion supports the sternum, the cranial portion supports the clavicle and / or the upper rib cage / costal cartilage , and the caudal portion supports the lower rib cage / costal cartilage and / or epigastric supported, thereby the breast is displaced outwardly so as to occupy the space, method.